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    Quality & RiskQuality SystemGlobal MarketsQSR / 21 CFR 820

    Quality System Regulation

    FDA's current good manufacturing practice (cGMP) requirements for medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The Quality System Regulation (21 CFR Part 820) sets out the cGMP requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use.

    What this means in practice

    FDA has harmonized the QSR with ISO 13485:2016 in the Quality Management System Regulation (QMSR), which becomes effective in 2026. Manufacturers must align procedures with the new framework.

    Cross-references

    Governs

    Things this term applies rules or requirements to.

    Contains

    Sub-elements or required artefacts of this term.

    Replaced by

    Has been superseded by a newer term.

    Overlaps with

    Covers some of the same ground; not interchangeable.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1FDA·2
    1. 1
      Quality System Regulation (21 CFR 820)
      Verified
      eCFRecfr.gov
    2. 2
      QMSR Final Rule
      Needs review
      FDAfda.gov
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.